Trading FDA, Clinical Trial Binary Events: $DEPO $EXAS $JAZZ $PYMX.OB

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

DepoMed (NASDAQ:DEPO) announced that it has reached a Special Protocol Assessment (SPA) agreement with the FDA for the design of the pivotal Phase 3 (BREEZE) clinical trial for SERADA (extended release gabapentin), which will be evaluated as a treatment for menopausal hot flashes. DEPO expects to complete the study during 3Q11 and report results during 4Q11, and the trial is designed to measure the drug effect assuming a placebo effect of 45-55% (based on historical trial data in trials for hot flashed) and  will enroll 600 patients with a 24-week treatment period.

PolyMedix (OTCBB:PYMX) reported that it has successfully completed a Phase Ib/II dose-ranging study and expects to begin a Phase 2 efficacy study for PMX-60056 (a synthetic, small molecule heptagonist compound) by year-end to reverse the blood-thinning effect of heparin in patients undergoing cardio-thoracic surgeries. The Company successfully completed a Phase 1b safety study in March 2010 for PMX-30063 (a small molecule mimetic of human defense proteins) and plans to conduct a Phase 2 efficacy study in patients with Staph (skin / soft tissue) infections, including drug-resistant strains of the bacteria.

Below are summaries of the most recent articles written by Mark Messier at www.BioRunUp.com — please visit his website to read the full articles, in addition to many other free tools and strategies related to binary event investing and trading…

Jazz Pharma (NASDAQ:JAZZ) Q2 Financials May Boost Share Price into FDA Panel…As mentioned previously, JAZZ announced Q2 earnings after hours today. The earnings report was much better than anticipated, and may provide a nice boost heading into the FDA Panel.  JAZZ briefly crossed the $10 barrier in after hours trading. I have attached some of the highlights from the earnings below: “For the second quarter of 2010, net [...

NY Times Article on EXACT Sciences (NASDAQ:EXAS)...On July 26th we released a write-up titled "EXAS- Data Validation Study with a 10/29/10 Catalyst Date".  We followed up on July 28th with the following article "EXAS Updates - Detection Technology Achieves 100% Sensitivity". Traders of EXAS should know that on August 10th the New York Times is publishing an article on Exact Sciences [...]

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